Timothy R. Cassity
President & Chief Executive Officer
Tim Cassity has 40+ years experience in Corporate Quality Management and Engineering, Management System Consulting, and Quality Managements System Assessments.
He has held executive level positions in industries from Electronics, Plastics, Fabrication, Transportation, and Pressure Vessel to Environmental Monitoring, Automotive, Aerospace, and Medical Device Manufacturing.
As a consultant, Mr. Cassity has worked with Fortune 100 and Fortune 500 clients such as Verizon/Bell Atlantic, Hewlett Packard, ITW, and General Electric. He has helped these companies develop, implement, and certify ISO 9001/QS 9000/AS 9100/ISO 13485/ISO 14001 /CMMI based management systems.
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Tim has attained credentialing in application of Six Sigma tools and has extensive Six Sigma project experience with several facilities. Mr. Cassity is a registered RABQSA ISO 9001 & 13485:2016 Quality Management System Lead Auditor. He has conducted over 1000 third party ISO certification audits in a variety of industries. His auditing expertise is routinely sought and contracted by the world's leading third party assessment firms (Registrars).
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Gary Waikle
Senior Quality System Consultant
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Quality Assurance Systems professional with over 35 years extensive hands-on manufacturing experience in Class II & III medical devices, pharmaceuticals, biologics and Hi-Rel electronic manufacturing. Experience leading an EU-MDR 2017/745 focused supplier quality team working with suppliers both domestic and foreign to assure regulatory compliance.
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Strong technical background in quality systems, quality control, and laboratory controls. Provided project management, new product design and development support, including application of statistical process controls and analytical testing.
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Provide consulting services to medical device, pharmaceutical and biologics industries focusing on compliance with U.S. 21 CFR 820, Part 1271, FDA MedWatch 3500A reporting, ISO 13485, EU MDR 2017/745 Compliance, Canadian Medical Devices 93/42/EEC (MDD),93/42/EEC (Medical Devices), CAPA, FMEA, Risk Assessment, HACCP and cGMP standards.
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Robert Holley
Senior Quality System Consultant
Robert Holley has over 20 years of experience working in quality environments within the vaccine, pharmaceutical and medical device industries. He has consulted within these industries over the past 10 years. Robert is at the subject matter expert level with Investigations and CAPA, as well as particulate issues.
He has a very strong background in Quality Systems, Quality Control and Supplier Quality, and also has significant experience leading investigation teams to troubleshoot manufacturing issues.
Robert has experience helping medical device companies remediate their CAPA programs and formulate site remediation plans in response to audits. He also has helped pharmaceutical companies remediate deviation backlogs and solve manufacturing problems. He regularly mentors and trains investigators within the pharmaceutical, vaccine and medical device industries.
Contact us today for a free
30-minute consultation with
one of our expert consultants.
QUALMETRICA L.L.C.
Highlands Ranch, CO. 80129
EMAIL: qms@qualmetrica.com
PHONE: 303-523-6444
